Kornimate/medical-research-clean huggingface dataset:
laparoscopic kasai has similar anesthetic outcomes to open kasai

Conditions: Biliary Atresia

Summary: biliary atresia (ba) is a rare biliary tree disease with a high incidence in eastern asia. kasai operation is a standard treatment for ba, and studies have shown that timely kasai operation is crucial for better outcomes. the kasai operation can be performed as either an open or laparoscopic technique. this study aimed to compare the differences in anesthetic management between the two surgical groups. herein, we compared the outcomes of infants with ba who underwent the open and laparoscopic kasai surgery.

biliary atresia is (ba) a rare biliary tree disease. this disease, which is usually found in infancy is characterized by biliary inflammation and obliteration. the incidence variate from 1 in 5000 to 20000. however, high prevalence rate up to 1 in 5-10,000 was comparatively noted in eastern asia, especially in japan and taiwan. biliary atresia can be treated by "kasai operation" ( kasai portoenterotomy) or liver transplantation. in the previous study, 60% of biliary atresia patients after receiving kasai portoenterostomy could have better liver prognosis.the timing of kasai operation is also crucial, increased age of surgery had negative influence in the long-term follow up. traditionally, kasai portoenterostomy was performed by open surgery. as the progression and popularity of minimally invasive surgery, laparoscopic kasai was first introduced in 2002 and then performed in many countries. however, the advantage of laparoscopic kasai seems still controversial due to many indicative outcomes as early jaundice clearance, native liver survival (nls) and liver transplantation rate within 1 year after the kasai operation even adhesions prevention seems no better maybe worse in laparoscopic group.but in our hospital, no statistically significant differences were observed for hospital stay and outcomes (including early jaundice clearance rate, episodes of cholangitis, and 2-year native liver survival rate) between the open and the laparoscopic kasai operations.even the better operation view was noted in laparoscopic group but operation time seems almost all prolonged in laparoscopic one compared to open one, that makes excessive fluid infusion and hypothermia easily found in laparoscopic group . however, no hypothermia and laryngeal edema were noted in our hospital compare to previous study

Eligibility criteria:
inclusion criteria: * children who had undergone kasai portoenterostomy between january 2011 and december 2021 exclusion criteria: * severe congenital heart disease requiring surgical treatment, * reoperation, * a diagnosis of non-biliary atresia, * incomplete medical records.
induction chemotherapy followed by short course radiotherapy in rectal cancer

Conditions: Rectal Cancer; Locally Advanced

Summary: a single-arm phase ii trial evaluating induction chemotherapy with folfirinoxm followed by short course radiotherapy (rt) in locally advanced rectal carcinoma

total neoadjuvant treatment (tnt) is currently the standard of care in the management of locally advanced rectal cancer since recent studies have shown improved pathological complete response and disease-free survival with this approach. however, survival benefits remain unproven. two strategies of tnt are validated so far : induction chemotherapy with folfirinox followed by long course radio-chemotherapy (rct) or short course rt (5x5 gy) followed by consolidation chemotherapy with capox (capecitabine and oxaliplatin) or folfox (5 fu and oxaliplatin) . the objective of investigators is to evaluate pathological complete response with a new strategy of tnt consisting in induction chemotherapy with folfirinoxm followed by short course rt and a delayed surgery.

Eligibility criteria:
inclusion criteria: * world health organization (who) performance status : 0 or 1 * histologically proven rectal adenocarcinoma \< 10 cm from anal margin on rectoscopy * clinically t3 (ct3) or clinically t4 (ct4) and/ or n+ non metastatic rectal cancer * neutrophil count \> 1500 e/mm3 * platelet count \>100000 * hemoglobin \> 10 g/dl ( transfusion allowed) * normal bilirubin level * creatinine clearance \> 50 ml/mn exclusion criteria: * distant metastases * history of chemotherapy or radiotherapy * grade 1 neuropathy * patient undergoing treatment for another cancer * active infection or severe comorbidities contraindicating chemotherapy
prevention of atrial fibrillation following esophagectomy

Conditions: Atrial Fibrillation; Esophagectomy

Summary: the investigators hypothesize that the medication amiodarone decreases the incidence of atrial fibrillation (af) following esophagectomy surgery. their specific aims are to: determine the effectiveness of amiodarone for the prevention of af following esophagectomy surgery; determine the influence of the prevention of af following esophagectomy surgery on post-surgical duration of stay in the intensive care unit icu)and duration of post-surgical hospital stay; and determine the safety of amiodarone for the prevention of af following esophagectomy surgery.

thousands of patients undergo major esophagectomy surgery in the united states each year, during which all or a portion of the esophagus is removed. a major complication of these surgeries is the occurrence of an irregular heartbeat known as atrial fibrillation (af), which develops in up to 40% of patients undergoing these procedures. af is characterized by rapid, irregular, chaotic beating of the two smaller chambers of the heart (the atria), leading to rapid, irregular beating of the two larger chambers (the ventricles). the average time to occurrence of post-surgical af is 2-3 days following surgery. af occurring following esophagectomy can result in extremely rapid heart rates, as fast as 150-200 beats per minute, and may be associated with serious consequences, including severely low blood pressure and potentially debilitating stroke. further, the risk of death following esophagectomy is significantly higher in patients who develop af compared with those who do not. therefore, the occurrence of this irregular heartbeat following esophagectomy is associated with severe, potentially life-threatening consequences. prevention of this irregular heartbeat in these patients may therefore be very important. amiodarone is a medication that is known to be effective for prevention and treatment of af that occurs in patients who have not undergone surgery. in addition, amiodarone has been shown to be effective for prevention of af following open-chest heart surgery. however, the use of medications for prevention of af following esophagectomy has not been well studied, and amiodarone has not been studied in a controlled trial for the prevention of af in this population. in addition, amiodarone is associated with side effects, and it is important to determine the safety of this medication when used in this patient population.

Eligibility criteria:
inclusion criteria: * males or females over the age of 40 * scheduled to undergo esophagectomy exclusion criteria: * history of atrial fibrillation * prior severe side effects from amiodarone * elevated liver enzymes \>3 times the upper limit of normal (unl) * corrected qt interval \> 450 ms * receiving class ia or class iii antiarrhythmics

Keywords: amiodarone atrial fibrillation surgical procedures, thoracic
evaluation of a resiliency intervention for siblings of children with autism spectrum disorder (asd)

Conditions: Stress

Summary: the proposed research has the following objectives: based off findings from the "development of a resiliency program for siblings of children with autism spectrum disorder" qualitative focus group study (protocol 2019p002284), the aim is to determine the feasibility and acceptability, of an 8-session relaxation response resiliency (sibchat) program for siblings of children with asd. we primarily aim to test the preliminary effectiveness of a pilot waitlist controlled trial on improving resiliency and stress coping, this will be assessed by comparing baseline-3 mo. scores on primary and secondary outcome measures between the immediate and waitlist control groups. among participants randomized to both conditions, we secondarily aim to investigate the extent of pre-post changes in primary and secondary outcomes. among immediate condition group only, we also aim to assess whether end-of-treatment (3 mo. post enrollment) improvements will be sustained at 6-mo. post enrollment.

this intervention will be a modified version of dr. elyse park's evidence-based 8-week multimodal treatment which is designed to promote adaptation to stress and promotion of resiliency. the program is an 8 session, 1 hour a week multi modal intervention that incorporates relaxation techniques, stress awareness discussion, and adaptive strategies for coping with stress. this study will refine an 8-session group virtual-delivered resiliency treatment program consisting of 8 virtual group 1-1 ½ hour sessions. the goal of this study would be to advance our ultimate objective to implement a national sibling resiliency program.

Eligibility criteria:
inclusion criteria: 1. age 14-17 years (inclusive of ages 14 and 17) 2. being the sibling of at least one individual with asd 3. access to internet or smart phone 4. english speaking exclusion criteria: 1. diagnosis of asd 2. past year psychiatric hospitalization there are no exclusion criteria with respect to ethnicity or socioeconomic status.

Keywords: resiliency training autism spectrum disorder family relationships
mild hypothermia in cardiogenic shock complicating myocardial infarction

Conditions: Acute; Myocardial Infarction, Complications; Cardiogenic Shock

Summary: prospective, randomized, single-center, controlled, open-label pilot-study to investigate whether induction of mild hypothermia in addition to primary percutaneous coronary intervention and optimal medical therapy in myocardial infarction complicated by cardiogenic shock improves cardiac power index after 24 h.


Eligibility criteria:
inclusion criteria: * acute myocardial infarction complicated by cardiongenic shock * patients on mechanical ventilation at time of randomization exclusion criteria: * out of hospital resuscitation with indication for mild hypothermia * mechanical complications after acute myocardial infarction * duration of cardiogenic shock \> 12 hours * age \> 90 years

Keywords: cardiogenic shock acute myocardial infarction mild hypothermia
a relative bioavailability study of revatio for the crushed tablets, extemporaneously prepared formulation, and the intact tablets at 20 mg dose in healthy volunteers

Conditions: Healthy

Summary: this will be a randomized, open-label, 3-treatment, 3-period, crossover, single-dose study in healthy subjects. eighteen (18) subjects will complete the study; dropouts may be replaced at the discretion of the sponsor. three treatments are: treatment a: revatio 20 mg intact tablet. treatment b: revatio 20 mg crushed tablet mixed with apple sauce. treatment c: revatio 20 mg extemporaneously prepared suspension (ep). blood samples for the analysis of sildenafil in plasma will be obtained pre-dose and up to 14 hours post dose in each period. tolerability and safety will be assessed by reported adverse events during each study period.


Eligibility criteria:
inclusion criteria: * healthy male/female subjects between the ages of 18 and 55 years, inclusive. healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ecg and clinical laboratory tests. * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). * an informed consent document signed and dated by the subject or a legally acceptable representative. * subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, ocular or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening. * history of febrile illness within 5 days prior to the first dose. * any condition possibly affecting drug absorption (eg, gastrectomy). * a positive urine drug screen.

Keywords: bioavailability revatio healthy volunteers
local administration of tranexamic acid in upper gastrointestinal hemorrhage

Conditions: Gastrointestinal Hemorrhage; Tranexamic Acid; Emergency Department; Antifibrinolytic Agents

Summary: upper gastrointestinal hemorrhage is a frequently diagnosis in emergency departments. although new drugs and endoscopic techniques were easily applied in various settings in this condition, the role of local administered therapies such as antifibrinolytic agents remain unclear. the investigators aimed to compare standard therapy (proton pump inhibitors, endoscopic treatments etc.) and standard therapy + local administered tranexamic acid in upper gastrointestinal hemorrhage in a double-blind, randomized trial.


Eligibility criteria:
inclusion criteria: * patients presenting with upper gastrointestinal hemorrhage to the ed * patients older than 18 years * patients who agree to participate the study by reading and signing the informed consent form exclusion criteria: * patients younger than 18 years * patients who do not agree to participate the study * documented or declared allergy to tranexamic acid * upper gastrointestinal hemorrhage secondary to trauma * upper gastrointestinal hemorrhage secondary to esophageal varices * patients who cannot undergo to endoscopy for any reason * history for thromboembolic disease * patients with renal impairment
gm-csf and thalidomide in treating patients undergoing surgery for high-risk prostate cancer

Conditions: Prostate Cancer

Summary: rationale: biological therapies, such as gm-csf, may stimulate the immune system in different ways and stop tumor cells from growing. thalidomide may stop the growth of prostate cancer by blocking blood flow to the tumor. giving gm-csf and thalidomide before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. purpose: this phase ii trial is studying how well giving gm-csf together with thalidomide works in treating patients undergoing surgery for high-risk prostate cancer.

objectives: * evaluate the impact of neoadjuvant sargramostim (gm-csf) and thalidomide on pathologic response (histologic p0, margin positivity, capsular penetration), prostate-specific antigen (psa) response, and other investigational endpoints in patients with high-risk prostate cancer undergoing prostatectomy. * determine the safety and feasibility of gm-csf and thalidomide. outline: this is an open-label study. patients receive sargramostim (gm-csf) subcutaneously on days 1, 3, and 5 and oral thalidomide on days 1-5 or 1-7 in weeks 1-4. treatment repeats every 4 weeks for 2 courses in the absence of unacceptable toxicity. patients undergo radical prostatectomy with bilateral pelvic lymphadenectomy at week 8 or 9. projected accrual: a total of 29 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed adenocarcinoma of the prostate meeting any of the following criteria for high-risk disease: * clinical stage ii or iii (t2b, t2c, or t3 with any grade or prostate-specific antigen \[psa\]) * gleason score 7 (4+3 only) or ≥ 8 (any stage or psa) * serum psa ≥ 10 ng/dl (any grade or stage) * any stage, psa, or gleason score with ≥ 35% chance of biochemical failure at 5 years based on kattan's nomogram * no clinical evidence of cns metastases * no metastatic disease as demonstrated by radiological exam (ct scan, mri, bone scan, x-ray) within 8 weeks of study entry * appropriate medical candidate for radical prostatectomy patient characteristics: * ecog performance status 0-1 * creatinine ≤ 2.0 mg/dl * granulocyte count ≥ 1,800/mm³ * platelet count ≥ 100,000/mm³ * ast \< 3 times upper limit of normal * bilirubin ≤ 1.5 mg/dl * fertile patients must use effective contraception during and for 4 weeks after completion of study treatment * no active unresolved infection * no pre-existing peripheral neuropathy \> grade 1 * no known hiv positivity * no other malignancy within the past 5 years except curatively treated basal cell or squamous cell carcinoma of the skin or controlled ta transitional cell carcinoma of the bladder * no known contraindication to sargramostim (gm-csf) or thalidomide prior concurrent therapy: * no prior radiotherapy to the prostate or pelvis * no prior chemotherapy or hormonal therapy for prostate cancer * no parenteral antibiotics within the past 7 days

Keywords: stage iii prostate cancer stage ii prostate cancer adenocarcinoma of the prostate stage i prostate cancer stage iv prostate cancer
long-term safety and efficacy study of mnd-2119 in patients with hypertriglyceridemia

Conditions: Hypertriglyceridemia

Summary: the purpose of this study is to evaluate the safety and efficacy of mnd-2119 at a dose of 2g/day or 4g/day for 52 weeks in patients with hypertriglyceridemia.


Eligibility criteria:
inclusion criteria: 1. participants diagnosed with hypertriglyceridemia. 2. participants with values of fasting triglyceride level are 150 mg/dl or higher and less than 500 mg/dl. exclusion criteria: 1. participants who have confirmed myocardial infarction and angina pectoris within 6 months. 2. participants who have aortic aneurysm or has received aortic aneurysmectomy within 6 months. 3. participants with, or with a history of, pancreatitis. 4. participants who have a history or complication of a clinically significant hemorrhagic disease within 6 months. 5. participants taking both anti-coagulants and anti-platelets. 6. participants receiving dual antiplatelet therapy (dapt). 7. participants taking direct oral anticoagulants (doac) or warfarin.
the development of a virtual reality program to improve attention in individuals with tbi

Conditions: TBI (Traumatic Brain Injury)

Summary: the purpose of this research is to investigate the effectiveness of a technique designed to improve divided attention and set-shifting impairments in persons with a traumatic brain injury (tbi). the study is designed to evaluate how well this technique can help people with tbi increase their attention and ability to function better in everyday life.

a pilot study will be conducted to evaluate the effectiveness of a technique designed to improve higher level attention (switching between tasks and multi-tasking) for persons with a traumatic brain injury. 32 individuals with tbi will be recruited. baseline assessment includes neuropsychological evaluation using traditional measures as well as a completion of a number of questionnaires designed to measure everyday attention and everyday functioning. participants are random assigned to either the experimental or control groups. experimental and control treatments include two 60 minute sessions, twice per week, for 5 weeks. follow-up assessment includes a neuropsychological evaluation using traditional measures as well as a completion of a number of questionnaires designed to measure everyday attention and everyday functioning. protocol efficacy will be determined by improvements between baseline and follow-up on several objective and functional measures of divided attention and set-shifting.

Eligibility criteria:
inclusion criteria: * between the ages of 18-65 * diagnosis of tbi * can read and speak english fluently exclusion criteria: * prior stroke or neurological disease other than tbi * unstable or uncontrolled seizures * currently taking benzodiazepines

Keywords: cognitive rehabilitation attention executive function
flopatch for prevention of hypotension after induction of general anesthesia

Conditions: Hypotension on Induction

Summary: this study is being conducted to find out if a special device called flopatch™, which sticks to a persons skin and uses ultrasound to check the blood flow in their neck, can tell if someone going to have low blood pressure after they get put to sleep for surgery. the investigators will be testing this in adults who are having elective non-heart surgery. basically, the goal is to see if this device can help predict who might have low blood pressure during surgery. hypotension is a common side-effect of general anesthesia induction, and is related to adverse outcomes, including significantly increasing risk of one-year mortality. even short durations of intraoperative hypotension have been associated with acute kidney injury (aki) and myocardial injury. myocardial injury after non-cardiac surgery (mins) is a common postoperative complication associated with adverse cardiovascular outcomes, and intraoperative hypotension is believed to be involved in its development. in the preoperative setting, a systematic review of 50 studies (2,260 patients) evaluating techniques to assess adult patients with refractory hypotension or signs of organ hypoperfusion found that half of all patients were fluid-responsive, pointing to volume status as a significant risk factor, while also presenting a challenge in distinguishing fluid-responders from non-responders. for surgical patients, preoperative fasting, hypertonic bowel preparations, anesthetic agents, and positive pressure ventilation all contribute to reduced effective circulating blood volume. optimized fluid therapy remains the cornerstone of treatment of hypovolemia, with excellent effectiveness. since the liberal use of fluids may result in fluid overload, which is associated with the development of pulmonary edema, wound infection, postoperative ileus, and anastomotic leakage, it is imperative to identify those patients who may benefit from it. the hypothesis is that the corrected flow time (cft) measured by the flopatch will help predict hypotension after the induction of general anesthesia.


Eligibility criteria:
inclusion criteria: * adult patients ≥ 18 years * undergoing elective noncardiac under general anesthesia exclusion criteria: * hypotension, defined as mean arterial pressure (map) below 65 mmhg preoperatively on the day of surgery. * treated with angiotensin converting enzyme inhibitors (ace-i) or angiotensin receptor blockers (arb) on the day of surgery. * patients with heart failure with ejection fraction (ef) \< 40%. * a history of any previous neck surgery or trauma. * cardiac rhythm other than sinus at the time of common carotid artery corrected flow time (cft) assessment. * patients who will receive neuraxial blockade (epidural or spinal) performed before induction of general anesthesia. * planned placement of a jugular central venous catheter or surgery to be performed in the area of the flopatch. * patient is pregnant or is undergoing obstetrical surgery.